Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
A changing competitive landscape: the role of the ITC in the biosimilars space
In the wake of President Trump's decision to withdraw from the Trans-Pacific Partnership, the other countries involved in negotiations (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore,...more
The U.S. and its 11 negotiating partners – Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam – reached preliminary agreement on October 5, 2015, on the Trans-Pacific...more
Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more
Trade ministers from 12 Pacific Rim countries announced, on October 5, 2015, that they had reached an agreement in principle on the Trans-Pacific Partnership (TPP). The TPP would arguably be the largest free trade agreement...more
Trade ministers announced that they will continue negotiations over several unresolved provisions of the Trans-Pacific Partnership (TPP) during a four-day meeting in Maui, Hawaii that concluded July 31. Trade ministers...more
A group of Democratic lawmakers and advocacy organizations criticized protections for brand-name biologics in the current draft of the Trans-Pacific Partnership, or TPP, a free-trade agreement among a dozen Pacific Rim...more
In a white paper released earlier this month, Professor Brook Baker of the Northeastern University School of Law argues that current trade agreements do not provide data exclusivity for biologics, and therefore, that the...more
Last month, in a letter to the U.S. Trade Representative, Ambassador Michael Froman, Biotechnology Industry Organization (BIO) President and CEO James Greenwood expressed support for the efforts of the Obama Administration to...more